Prospective Study in Pelvic Radiotherapy Patients

September 21, 2005 updated by: Royal Marsden NHS Foundation Trust

A Prospective Study to Identify Changes in Nutritional Status and Bowel Symptoms in Patients Receiving a Course of Radical Radiotherapy to the Pelvis for Treatment of Gynaecological, Urological or Rectal Cancer.

Symptoms such as diarrhoea and abdominal discomfort are common side effects of radiotherapy for tumours in the pelvis and usually occur within 2 weeks of starting treatment. Once the course of radiotherapy has been completed these symptoms usually subside, but in some patients they may continue and sometimes cause significant problems.

It is not clear what processes are occurring to trigger such symptoms. There are a number of possibilities and we would like to investigate these further. If we can identify specific reasons for symptoms being worse in one patient compared to another, then we can try to either prevent or treat these. The aim of this study is to look for differences in the way that the bowel adapts to radiotherapy in patients who do and those who don't experience bowel symptoms during their course of radiotherapy.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients with pelvic cancers may be treated with radical radiotherapy as part of their disease management. Acute intestinal changes such as diarrhoea, abdominal pain and nausea ocur in about 75% of patients. Severe acute changes predispose to chronic, intractable intestinal changes. Nutritional intervention during radiotherapy may protect the bowel from toxicity.

A number of nutritionally related changes in bowel function may cause acute intestinal problems during radiotherapy. These include: Bile-acid & pancreatic enzyme potentiated damage to mucosa causing loss of epithelial integrity and in turn increased permeability to antigens and luminal bacteria; Bile-acid malabsorption, decreasing the gut's ability to digest fat; Reduced disaccharidase activity due to loss of the intestinal brush border, causing malabsorption of sugars leading to osmotic diarrhoea; Statis/ dysmotility in the small intestine prompting bacterial overgrowth.

There is little prospective data in patients undergoing radiotherapy to help to identify which are important. To understand what changes are relevant during a 6-week course of radiotherapy we plan this prospective observational study. Any changes identified in this study could be ameliorated by specific nutritional intervention in future studies.

Study Type

Observational

Enrollment

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient with gynaecological, bladder or rectal malignancy about to embark ona 5-6 week course of radical radiotherapy to the pelvis who is able to give informed consent

Exclusion Criteria:

  • Patients unable or unwilling to give informed consent
  • Patients who have already started radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Jervoise Andreyev, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2005

Last Update Submitted That Met QC Criteria

September 21, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR2240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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